FrailtyNCT05010720
Prevelance of Frailty and Its Associated Factors in Patients With Axial Spondyloarthritis
An observational study of Frailty and Axial Spondyloarthritis, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Axial Spondyloarthritis is an inflammatory arthritis disease and its main symptoms are chronic pain and stiffness, causing structural damage to the spinal vertebrae. Axial Spondyloarthritis leads to physical disability and a decrease in the level of physical activity. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Frailty, Axial Spondyloarthritis
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2021to 10 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Axial Spondyloarthritis in a tertiary research and training hospital
Who may be able to join
- Diagnosed with Axial Spondyloarthritis by an experienced rheumatologist.
- To be between the ages of 40-65
Who cannot join
- Severe comorbidities such as cancer and stroke
- Being diagnosed with newly defined or recurrent cancer,
- Not having enough cognitive skills to answer the questions,
- Having neurological problems such as stroke
- Having cognitive impariment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpaşa Numune Research and Training Hospital
Istanbul
About this study
Axial Spondyloarthritis is an inflammatory arthritis disease and its main symptoms are chronic pain and stiffness, causing structural damage to the spinal vertebrae. Axial Spondyloarthritis leads to physical disability and a decrease in the level of physical activity.
Frailty is a syndrome characterized by decline in physiological reserve and loss of muscle strength. Frailty can lead to vulnerability of individuals to possible injuries and a decrease in independence, and ultimately an increase in mortality. Although frailty is associated with older adults, it has been reported that it can be detected in patients with cancer, diabetes and rheumatological diseases and it is not related with age. Frailty has been reported to be a reversible and a treatable condition.
The aim of our study was to investigate the prevalence of frailty and the relationship between frailty and disease activity, physical functional level, quality of life and other associated factors in individuals with Axial Spondyloarthritis.
- Conditions
- Frailty, Axial Spondyloarthritis
- Medical subject headings
- Frailty, Axial Spondyloarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Fried Frailty Phenotype
The frailty level of the participants included in the study will be determined according to the frailty phenotype criteria of Fried et al. criteria for the diagnosis of frailty; Decreased grip strength, walking speed for 4 meters is less than the determined metrics ( for people who are 159 cm and shorter as <6.12 sec or >5.25 sec for those 159 cm and above), involuntary weight loss in the last year (≥4.5 kg) or body mass index ≤18.5 kg/m2, low physical activity level, and increased fatigue level reported by the participant. Individuals meeting 3 or more of these criteria are defined as "frail", individuals meeting 1 or 2 criteria are defined as "pre-fragile (pre-fragile) and individuals who do not meet any criteria are defined as "normal or robust".
Measured: 1 day
Kihon Checklist
Frailty status will determined according to the Turkish version of the Kihon Checklist (KCL) which consists of 25 questions for yes (1) or no (0) answers. KCL includes seven categories as; physical function (5 items), mood (5 items), instrumental activities of daily life (5 items), nutrition (2 items), oral function (3 items), memory (3 items) and socialization (2 items). Total KCL scores range from 0 to 25 and scores ≥8 indicate frailty, between 4 to 7 indicate pre-frailty and between 0 to 3 indicate robustness.
Measured: 1 day
Short Physical Performance Battery(SPPB)
SPPB can be used to determine frailty status. It comprises 3 parameters: static balance, sit to stand test and walking speed. Scores above 9 indicates no frailty, between 7 to 9 indicates pre-frailty and below 7 indicates frailty status.
Measured: 1 day
Secondary outcomes (4)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI evaluates disease-specific symptoms such as fatigue, joint pain, and morning stiffness in individuals with Ankylosing Spondylitis between 0 and 10. A high score is expressed by an increase in disease activity.
Measured: 1 day
Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI has been developed to determine the functional status of individuals with Ankylosing Spondylitis and evaluates the perceived stress level in daily activities between 0 and 10 (0 = easy and 10 = impossible). Activities such as bending, reaching, standing, changing positions, climbing stairs are questioned. The total score is determined by dividing the sum of the scores from each item by 10, and "0" is defined as the best score and "10" as the worst score.
Measured: 1 day
Depression and Anxiety
Depression and anxiety status of the included patients will be evaluated with the Turkish version of the Hospital Anxiety and Depression Scale (HADS). This scale consists of 14 items; 7 for depression symptoms and 7 for anxiety symptoms. Each answer is scored 0 to 3. Cut-off values for the Turkish version are 7 and 10 for depression and anxiety subscales, respectively.
Measured: 1 day
Ankylosing Spondylitis Quality of Life Scale
The Turkish version of the Ankylosing Spondylitis Quality of Life (ASQOL) scale will be used to assess disease-related quality of life. ASQOL includes 18 items with dichotomous responses (yes/no) evaluating the impact of disease on social life, sleep, motivation, mood, coping, independence and activities of daily living, The score ranges between 0 to 18 and higher score indicates reduced quality of life.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start12 Aug 2021
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özgül Öztürk, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010720
- Sponsor's protocol ID
- ATADEK 2021/14
- Status last verified
- Jun 2022
- First submitted
- 12 Aug 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Frailty and Its Associated Factors in Patients With Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT05010720
- Acronym / sponsor ID
- ATADEK 2021/14
- Conditions
- Frailty, Axial Spondyloarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Axial Spondyloarthritis is an inflammatory arthritis disease and its main symptoms are chronic pain and stiffness, causing structural damage to the spinal vertebrae. Axial Spondyloarthritis leads to physical disability and a decrease in the level of physical activity.
Frailty is a syndrome characterized by decline in physiological reserve and loss of muscle strength. Frailty can lead to vulnerability of individuals to possible injuries and a decrease in independence, and ultimately an increase in mortality. Although frailty is associated with older adults, it has been reported that it can be detected in patients with cancer, diabetes and rheumatological diseases and it is not related with age. Frailty has been reported to be a reversible and a treatable condition.
The aim of our study was to investigate the prevalence of frailty and the relationship between frailty and disease activity, physical functional level, quality of life and other associated factors in individuals with Axial Spondyloarthritis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Axial Spondyloarthritis in a tertiary research and training hospital
Key inclusion criteria (2 listed)
- Diagnosed with Axial Spondyloarthritis by an experienced rheumatologist.
- To be between the ages of 40-65
Key exclusion criteria (5 listed)
- Severe comorbidities such as cancer and stroke
- Being diagnosed with newly defined or recurrent cancer,
- Not having enough cognitive skills to answer the questions,
- Having neurological problems such as stroke
- Having cognitive impariment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fried Frailty Phenotype
Time frame: 1 day
The frailty level of the participants included in the study will be determined according to the frailty phenotype criteria of Fried et al. criteria for the diagnosis of frailty; Decreased grip strength, walking speed for 4 meters is less than the determined metrics ( for people who are 159 cm and shorter as <6.12 sec or >5.25 sec for those 159 cm and above), involuntary weight loss in the last year (≥4.5 kg) or body mass index ≤18.5 kg/m2, low physical activity level, and increased fatigue level reported by the participant. Individuals meeting 3 or more of these criteria are defined as "frail", individuals meeting 1 or 2 criteria are defined as "pre-fragile (pre-fragile) and individuals who do not meet any criteria are defined as "normal or robust".
Kihon Checklist
Time frame: 1 day
Frailty status will determined according to the Turkish version of the Kihon Checklist (KCL) which consists of 25 questions for yes (1) or no (0) answers. KCL includes seven categories as; physical function (5 items), mood (5 items), instrumental activities of daily life (5 items), nutrition (2 items), oral function (3 items), memory (3 items) and socialization (2 items). Total KCL scores range from 0 to 25 and scores ≥8 indicate frailty, between 4 to 7 indicate pre-frailty and between 0 to 3 indicate robustness.
Short Physical Performance Battery(SPPB)
Time frame: 1 day
SPPB can be used to determine frailty status. It comprises 3 parameters: static balance, sit to stand test and walking speed. Scores above 9 indicates no frailty, between 7 to 9 indicates pre-frailty and below 7 indicates frailty status.
4 secondary outcomes
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 1 day
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 1 day
Depression and Anxiety
Time frame: 1 day
Ankylosing Spondylitis Quality of Life Scale
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Axial Spondyloarthritis, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fried Frailty Phenotype (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.